Latest Artificial Cervical Disc Companies Update
June 2023: The IDE clinical study being conducted by Synergy Spine Solutions is now complete. The goal of the 1-Level Synergy Disc study is to compare the effectiveness of the Synergy Disc device to the gold standard of care for individuals with degenerative disc disease (DDD): anterior cervical discectomy and fusion. Patients participating had unilateral symptoms affecting any cervical level from the third to the seventh and were resistant to non-invasive treatments. Primary outcomes include the Neck Disability Index, neurological evaluation, the need for further surgery, and device-related complications evaluated at two years post-operatively. The MCRA is helping with a multi-center, prospective, non-randomised, historically controlled study. Based on the results of the experiment, the orthopedic medtech business plans to submit an application for pre-market approval to the FDA in the United States.
August 2023: In a news statement issued, ZimVie Inc. said that the FDA granted clearance to the company's 4.5-mm Mobi-C artificial disc for use in cervical disc replacement procedures. The approval of a 4.5-mm Mobi-C disc allows surgeons additional option to fit the architecture of patients having cervical disc replacement at one level or two contiguous levels, according to the announcement. With the approval of the 4.5-mm Mobi-C, our surgeons and patients have won, and our global regulatory affairs team has been validated for their strategic thinking in using real-world clinical evidence gained from [European Union] studies to demonstrate long-term safety and efficacy and win FDA approval for the smaller disc.List of Artificial Cervical Disc Key companies in the market
- Globus Medical Inc (US)
- Zimmer Biomet Holdings Inc. (US)
- Braun Melsungen AG (Germany)
- Centinel Spine, LLC (Switzerland)
- Medtronic PLC (Ireland)
- Nuvasive Inc. (US)
- Johnson & Johnson (US)
- Orthofix Company (US)
- Alphatec Spine (US)
- Simplify Medical (US)
- AxioMed (US)
- Aditus Medical (Germany)
- FH Orthopedics (France)
- Medicrea (France)
- Spineart (Switzerland)